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510(k) K223294

SpineJack® Expansion Kit by Stryker Instruments — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2022
Date Received
October 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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